TOP2A FISH PHARMDX KIT
FDA premarket approval P050045/S003 · decided 2011-11-10
Approval details
- PMA number
- P050045
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TOP2A FISH PHARMDX KIT
- Generic name
- Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
- Applicant
- Dako Denmark A/S
- Date received
- 2011-10-06
- Decision date
- 2011-11-10
- Days to decision
- 35 days
- Decision code
- OK30
- Product code
- NXG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Glostrup
- Statement
- ADD AN ALTERNATE SUPPLIER OF TEXAS RED LABELED DCTP NUCLEOTIDE AND TO REPLACE AN IN-PROCESS QC PROCEDURE WITH A NEW QC TEST ON FFPE BREAST CANCER TISSUE.
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